Pressure or pulse irrigation has been shown to decrease infection rates in open wounds. During pulse irrigation the wound is bathed with a small stream of compressed air/fluid (generally a saline solution) at relatively high pressure to dislodge dead tissue and foreign contamination. Pressures up to 70 to 75 psi are used to attain the desired beneficial results. As little as 250 cc of irrigation fluid may be used in the procedure, but often as much as three (3) to six (6) liters of fluid are used to ensure proper cleansing and of the wound and removal of end coverage. Many hand, foot and other open injuries occur each year for which pulse irrigation provides beneficial results. Additionally, pulse irrigation is used in a number of operative procedures such as prosthetic joint replacement, in which it is used to remove bone fragments from the area of prosthesis.
Under current practices, however, the person performing the pulse irrigation and those other surgical support personnel in the immediate area are placed at risk of contracting infectious diseases borne in contaminated irrigation materials which splash off the open wound (including an area of surgery), are aerosolized or otherwise escape into the surrounding atmosphere. Some pulse irrigation systems are equipped with partial shields to prevent splashing of contaminated materials directly back toward the operator, but do not prevent peripheral splashing (which can soak the shoes of the operator and others in the periphery as well the floor and drapes) or aerosolization. The resultant risk of infection from such escaping materials during treatment of wounds in individuals with infectious diseases, such as AIDS and hepatitis, makes pulse irrigation a possibly dangerous procedure to a treating physician and attending staff. It would therefore be highly desirable and advantageous to develop an enclosure system for use during pulse irrigation to isolate contaminated irrigation fluids and tissue from those persons in proximity to the patient.
Even before the recent discovery of the benefits of pulse irrigation, wounds have been treated with numerous fluids using a number of procedures to induce proper healing. Various enclosures have been developed to keep such fluids in proximity to the wound undergoing treatment. In U.S. Pat. No. 3,288,140 issued to McCarthy, for example, a method and apparatus for treatment of surface wounds by fluids is disclosed. The McCarthy apparatus comprises a cup or chamber into which a fluid is introduced. The cup provides a sealed chamber around the wound. The cup is first filled with fluid and then additional fluid is injected through an inlet to create a stirred bath. The apparatus is also provided with an outlet located above both the wound and the inlet to allow excess fluid to exit the cup or chamber. The cup is manufactured from plastic, hard rubber, porcelain and other materials impervious to the fluid being used. The inlet tube is disposed within the cup so as to allow angular movement but to prevent axial movement. The patient being treated with the device can thus change the angle of the inlet tube to direct the path of incoming fluid to different areas of the wound.
The use of fluids in treating infections has also been used in the treatment of animals. In U.S. Pat. No. 2,839,052, issued to Verch, et al., a device for treating infections in animals is disclosed. The device is particularly suited to the treatment of mastitis infection in female animals, and is particularly directed to the infection of the mammary glands of cows. The Verch, et al. device includes a cup or chamber into which an inlet tube is connected. Fluid is introduced into the chamber so as to create a turbulent flow around the affected area similar to the action of a whirlpool. The stimulation of the affected area causes an increase in blood flow to that area, which helps in the treatment of the infection.
A similar device for the washing and cleansing of an udder and teat is disclosed in U.S. Pat. No. 3,713,423 issued to Sparr. The Sparr device includes a cup which is positioned to accommodate the teat of a COW. The bottom of the cup includes a valving means having an enclosed nipple which aims the solution towards the opening of the teat where the infection (mastitis) usually starts. The solution in the cup is in a state of swish-swashing turbulence and is suitably drained via an outlet tube.
Cups or chambers into which an irrigating fluid is injected have also been used to remove obstructions from the human eye. In U.S. Pat. No. 4,798,599, issued to Thomas, for example, an eye cup having a rim portion that conforms to the orbit portion which surrounds the eye is disclosed. The eye cup is placed over the eye and forms a liquid-confining chamber adjacent to the eye. The skin above and below the eye is drawn away from the eye with the eye cup being pushed against the skin so that the rim portion applies sufficient pressure against the skin to hold the eye open. Eyewash is delivered to the eye and drained from the chamber via inlets and outlets, respectively. The eyewash is delivered into the chamber so as to contact the side of the eye and not the cornea directly, thereby preventing blepharal spasms.
Portable enclosures or chambers have also been used in connection with the inducement of healing of wounds by hyperbaric oxygenation treatment. In U.S. Pat. No. 4,772,259, issued to Frech, et al., a hyperbaric oxygenation apparatus comprising a chamber in the form of a disposable inflatable bag of impervious, synthetic resinous material is disclosed. The chamber is designed to fit over the affected area and forms a non-leak enclosure into which oxygen can be introduced through a single port in fluid connection with the chamber. The pressure of the oxygen in the chamber is pulsated between maximum and minimum positive values. The patient cyclically experiences first a medicinal increase in the blood gas level in the limb under treatment with a corresponding restrictive blood flow and, thereafter, a progressive return to normal blood flow rates in the limb of the patient as the pressure in the chamber changes from maximum to minimum positive pressure. The pressure loss problem associated with prior portable hyperbaric oxygenation apparatus was solved by a novel cuff or sleeve preventing inversion under positive pressure. A portable hyperbaric oxygen chamber is also disclosed in U.S. Pat. No. 3,744,491.
Similarly, in U.S. Pat. No. 3,610,238, issued to Rich, a wound infection prevention device is disclosed which comprises a porous pad encased in an air-impervious bag to which the upper and lower surfaces of the pad are attached. The device includes an annular channel surrounding the periphery of the pad to which air may be fed under pressure via a single air inlet port. The device is placed around a wound on the skin of the patient and air is fed into the annular chamber. The air passes through the porous pad and then flushes upwardly over the wound to prevent dust and airborne bacteria from falling upon the wound.
None of the above devices provides a chamber or enclosure suitable for use during pulse irrigation of a wound to isolate contaminated materials from those persons in the immediate area of the procedure. Enclosures previously designed for use with liquid treatment cannot withstand the relatively high pressures used in pulse irrigation without leakage, aerosolization or other escapage of the liquid or contaminated material. The person performing pulse irrigation also needs to have an unobstructed view of the wound. Furthermore, the operator should have freedom to maintain substantially complete control over the position of the pulse irrigation nozzle to adequately control the direction of the pulse. Moreover, because pulse irrigation is used under the time constraints experienced in operating room and emergency room procedures, a device developed for use with pulse irrigation should be capable of quick yet substantially fail-safe application.